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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC Back to Search Results
Catalog Number 72404231
Device Problems Cylinder; Material Rupture
Event Date 08/14/2018
Event Type  Injury  
Manufacturer Narrative

The ams700 device was visually inspected and functionally tested. There was a leak in one cylinder that was the result of fatigue in the inner tube and fold wear of the outer tube. The cylinder had broken fabric threads. The other cylinder performed within specifications. The pump was not functionally tested due to the cylinder leak and contamination.

 
Event Description

It was reported that the patient had his ams700 inflatable penile prosthesis replaced due to "cylinder rupture, bilateral. No patient complications were reported in relation with this event. This complaint was initially submitted to fda via asr report q3 2018 and additional information was received by boston scientific. Due to the removal of exemption e1997037, this information is provided via supplemental report.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka , MN 55343
9529306000
MDR Report Key8090205
Report Number2183959-2018-00131
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/17/2011
Device Catalogue Number72404231
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/20/2018 Patient Sequence Number: 1
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